Peritoneal Dialysis (PD) is a dialysis treatment that differs from Hemodialysis (HD) because blood is not removed from the body and passed through a dialyzer, but a catheter is placed in the peritoneal cavity and peritoneal dialysis fluid is cycled into and out of the peritoneal cavity to accomplish dialysis. Blood is cleaned inside the patient using the patient's own peritoneum as a type of dialysis membrane. The two primary classes of PD are Continuous Ambulatory Peritoneal Dialysis (CAPD) and Continuous Cycling Peritoneal Dialysis (CCPD) (or Automated Peritoneal Dialysis (APD)). In CAPD, dialysis is performed continuously by positioning a bag of peritoneal dialysate at shoulder level and using gravity to introduce the fluid into the peritoneal cavity. After a period of time the used dialysate is then drained from the cavity and discarded. The time period that the dialysate is in the cavity is called the dwell time and can range from 30 minutes to 4 hours or more. CAPD is typically performed three, four or five times in a 24-hour period while a patient is awake. CAPD requires no cycler to deliver and remove the fluid.
Continuous Cycling Peritoneal Dialysis (CCPD) or Automated Peritoneal Dialysis (APD) uses a machine called a cycler to fill and empty the peritoneal cavity multiple times during a particular therapy session. The machine (cycler) delivers and then drains the peritoneal dialysate. Typically, CCPD is performed at night while the patient is asleep. In some cases, a patient may require a combination of CAPD and CCPD to receive an appropriate treatment. For example, some patients use a cycler at night for CCPD but also perform one or more manual CAPD exchanges during the day.
The effectiveness of CCPD can depend on several factors, unique to specific patients. The factors, including the number of cycles in a session, the dwell time of a cycle, the volume of a cycle, and the composition of the peritoneal dialysate, can influence patient comfort and therapy effectiveness. Further, changes to the patient during a cycle can result in less effective therapy from subsequent cycles within the same peritoneal dialysis session. Yet, known CCPD systems do not provide any mechanism to make changes to peritoneal dialysis cycles within a peritoneal dialysis session based on the changing needs of a patient during a single therapy session. Rather, known CPPD are restricted to automatically functioning based on pre-programmed settings without adjustment from cycle to cycle. Importantly, the known systems must rely on set pre-programmed settings because the known systems and methods lack the capability to create or adjust peritoneal dialysate based on newly received data.
Hence, there is a need for systems and methods that can modify one or more patient or dialysis machine parameters from cycle-to-cycle, or “intra-session,” within a therapy session to optimize peritoneal dialysis therapy and patient comfort. There is also a need for systems and methods to generate peritoneal dialysate in accordance with any adjusted dialysate prescription. The need includes optimizing multiple cycles or exchanges over a dialysis therapy session and requires the use of systems and methods capable of creating or adjusting a peritoneal dialysate.